The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

N/ACompletedNCT04198207

Beijing Children's Hospital70 enrolled

Overview

Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.

This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tuberous Sclerosis Complex Epilepsy

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age Range: Patients aged 1 to 18 years. * Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria. * Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy). * Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form. Exclusion Criteria： * Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases. * Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder). * Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety. * Drug Allergy: Known allergy to drugs used in the study. * Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy. * Pregnancy or Lactation: Pregnant or breastfeeding individuals. * Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.

Locations (1)

Beijing Children's Hospital

Beijing, China

Outcomes

Primary Outcomes

% of patients with Mchugh grading

The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.

Time frame: 4 years

Secondary Outcomes

Wechsler Intelligence Scale is used for the evaluation of IQ

Time frame: 3 years

Quality of Life: QOLIE-31

QOLIE-31 is suitable for patients 14 years and older. QOLCE-76 is applied to patients aged 2-13 by parents.

Time frame: 3 years

Data from ClinicalTrials.gov

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